Contributions
Abstract: EP1636
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: In pivotal studies, Alemtuzumab infusion-associated reactions (IARs) occurred in a majority (>90%) of patients despite using of prophylactic treatment; 3% were serious.
Objectives: To describe the most relevant IARs and its temporal pattern in routine clinical practice in 11 centres of the Northwest of Spain.
Methods: Eighty three patients: 55 (66%) females and 28 (34%) males, who received first dose Alemtuzumab were included. Mean age was 39.4±8.27 years. The median duration of follow up was 11.0±5.88 months; 30 patients received the second course.
Alemtuzumab infusion was given over approximately 5 hours. Patients received daily previous standarized pre-medication regimen: antihistamines, proton-pump inhibitors, diphenhydramine, acetaminophen and methylprednisolone (MP). 1g MP was administered on infusion day 1-3 of each course and 500 mg on day 4-5. IARs was observed and managed with symptomatic treatments as needed during and post-infusion. All IARs and its severity were collected.
Results: IARs occurred in 67 (81%) patients and all were mild to moderate in severity.
The 1st infusion day pyrexia and headache were the most frequent IARs. On infusion days 3rd to 5th, the most prominent IARs were rash and urticaria, being observed until 72 hours after the last infusion day. Similar temporal pattern of IARs was observed in the first and the second courses. IARs were less frequent during course 2 (mean 2.3±2.33 events/patient) than during course 1 (mean 3,4±3.45 events/patient).
Conclusions: In our clinical experience, IARs were less frequent that in clinical trials and no serious IARs occurred.
It is interesting to observe that IARs have a characteristic temporal pattern of presentation. Pyrexia and headache were typically observed on the first day. Rash and urticaria were more frequent on infusion days 3rd to 5th.
It is remarkable that rash and urticaria persisted even for 72 hours after the last infusion day; therefore, it is important to inform to the patient about this; it will improve patient care.
Disclosure:
López Real A.M. has served as speaker for Biogen Idec, Merck Serono, Genzyme, Novartis and TEVA;
Peña Martínez J. has served as speaker for Sanofi Genzyme, Merck, Bayer, Teva, Biogen Idec, Novartis,
Almirall, Krka and Qualigen; Gonzalez Quintanilla V. has served as speaker for Biogen, Almirall, Merck, Teva, Sanofi-Genzyme, Allergan, MSD and Novartis. He has also participated in clinical trials for AMGEN, Lilly, Sanofi-Genzyme, Allergan y Novartis;
Solar Sanchez D.M. has served as consultant for Almirall, Biogen, Bayer, Merck, Novartis, Sanofi-Genzyme, TEVA.
Gonzalez Suarez I. has received grants from Biogen, Novartis, Genzyme;
Pato Pato A. has received grants for clinical research from Biogen, Novartis, Genzyme, Almirall, Bayern;
Amigo Jorrín C. has served as speaker for Sanofi, Novartis, Biogen and Teva;
Aguado Valcarcel M. has served as speaker for Biogen, Sanofy Genzyme, TEVA, Novartis, Bayer and MERK-Serono;
Alvarez Rodriguez E. has served as speaker or consultan for Sanofi, Biogen and Merck Serono;
Arias Gomez, M., has served as advisor for Merck, Biogen-Idec, Genzyme, Roche, Novartis, TEVA, Actelion and Jansen;
Lorenzo J.R., has served as speaker and received grants for clinical research from Biogen, Novartis, Genzyme, Almirall, Bayern;
Alvarez Fernández L., Lema Devesa D. and Cacabelos Perez, P. nothing to disclose; Oterino Duran A., has served as speaker for Biogen, Almirall, Merck, Teva, Sanofi-Genzyme, Allergan, MSD and Novartis.
Abstract: EP1636
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: In pivotal studies, Alemtuzumab infusion-associated reactions (IARs) occurred in a majority (>90%) of patients despite using of prophylactic treatment; 3% were serious.
Objectives: To describe the most relevant IARs and its temporal pattern in routine clinical practice in 11 centres of the Northwest of Spain.
Methods: Eighty three patients: 55 (66%) females and 28 (34%) males, who received first dose Alemtuzumab were included. Mean age was 39.4±8.27 years. The median duration of follow up was 11.0±5.88 months; 30 patients received the second course.
Alemtuzumab infusion was given over approximately 5 hours. Patients received daily previous standarized pre-medication regimen: antihistamines, proton-pump inhibitors, diphenhydramine, acetaminophen and methylprednisolone (MP). 1g MP was administered on infusion day 1-3 of each course and 500 mg on day 4-5. IARs was observed and managed with symptomatic treatments as needed during and post-infusion. All IARs and its severity were collected.
Results: IARs occurred in 67 (81%) patients and all were mild to moderate in severity.
The 1st infusion day pyrexia and headache were the most frequent IARs. On infusion days 3rd to 5th, the most prominent IARs were rash and urticaria, being observed until 72 hours after the last infusion day. Similar temporal pattern of IARs was observed in the first and the second courses. IARs were less frequent during course 2 (mean 2.3±2.33 events/patient) than during course 1 (mean 3,4±3.45 events/patient).
Conclusions: In our clinical experience, IARs were less frequent that in clinical trials and no serious IARs occurred.
It is interesting to observe that IARs have a characteristic temporal pattern of presentation. Pyrexia and headache were typically observed on the first day. Rash and urticaria were more frequent on infusion days 3rd to 5th.
It is remarkable that rash and urticaria persisted even for 72 hours after the last infusion day; therefore, it is important to inform to the patient about this; it will improve patient care.
Disclosure:
López Real A.M. has served as speaker for Biogen Idec, Merck Serono, Genzyme, Novartis and TEVA;
Peña Martínez J. has served as speaker for Sanofi Genzyme, Merck, Bayer, Teva, Biogen Idec, Novartis,
Almirall, Krka and Qualigen; Gonzalez Quintanilla V. has served as speaker for Biogen, Almirall, Merck, Teva, Sanofi-Genzyme, Allergan, MSD and Novartis. He has also participated in clinical trials for AMGEN, Lilly, Sanofi-Genzyme, Allergan y Novartis;
Solar Sanchez D.M. has served as consultant for Almirall, Biogen, Bayer, Merck, Novartis, Sanofi-Genzyme, TEVA.
Gonzalez Suarez I. has received grants from Biogen, Novartis, Genzyme;
Pato Pato A. has received grants for clinical research from Biogen, Novartis, Genzyme, Almirall, Bayern;
Amigo Jorrín C. has served as speaker for Sanofi, Novartis, Biogen and Teva;
Aguado Valcarcel M. has served as speaker for Biogen, Sanofy Genzyme, TEVA, Novartis, Bayer and MERK-Serono;
Alvarez Rodriguez E. has served as speaker or consultan for Sanofi, Biogen and Merck Serono;
Arias Gomez, M., has served as advisor for Merck, Biogen-Idec, Genzyme, Roche, Novartis, TEVA, Actelion and Jansen;
Lorenzo J.R., has served as speaker and received grants for clinical research from Biogen, Novartis, Genzyme, Almirall, Bayern;
Alvarez Fernández L., Lema Devesa D. and Cacabelos Perez, P. nothing to disclose; Oterino Duran A., has served as speaker for Biogen, Almirall, Merck, Teva, Sanofi-Genzyme, Allergan, MSD and Novartis.